U.S. patent number 8,551,058 [Application Number 11/775,477] was granted by the patent office on 2013-10-08 for endoscopic translumenal surgical systems.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. The grantee listed for this patent is Michael S. Cropper, John P. Measamer. Invention is credited to Michael S. Cropper, John P. Measamer.
United States Patent |
8,551,058 |
Measamer , et al. |
October 8, 2013 |
Endoscopic translumenal surgical systems
Abstract
Devices are provided herein for translumenal access to a
treatment site within a body cavity. In general, the devices
include an elongate sleeve configured to provide access to a
treatment site wherein various portions of the sleeve are
associated with an anti-microbial agent. Additionally, the
anti-microbial agent(s) can be disposed within a housing and/or
inner lumen of the sleeve such that surgical instruments passing
therethrough can be sterilized en route to and/or being withdrawn
from the treatment site. Additionally, various methods are also
provided herein for maintaining the sterility of a treatment
site.
Inventors: |
Measamer; John P. (Cincinnati,
OH), Cropper; Michael S. (Edgewood, KY) |
Applicant: |
Name |
City |
State |
Country |
Type |
Measamer; John P.
Cropper; Michael S. |
Cincinnati
Edgewood |
OH
KY |
US
US |
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Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
|
Family
ID: |
38454942 |
Appl.
No.: |
11/775,477 |
Filed: |
July 10, 2007 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20080051735 A1 |
Feb 28, 2008 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11382173 |
May 8, 2006 |
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Current U.S.
Class: |
604/265;
604/164.01; 604/158; 606/108; 604/167.01 |
Current CPC
Class: |
A61B
1/00087 (20130101); A61B 17/3417 (20130101); A61B
1/00135 (20130101); A61B 17/3462 (20130101); A61B
1/3132 (20130101); A61B 1/273 (20130101); A61B
2017/00889 (20130101); A61B 2017/2905 (20130101); A61B
2017/00296 (20130101); A61B 2017/00278 (20130101); A61B
2017/3441 (20130101) |
Current International
Class: |
A61M
5/178 (20060101); A61M 5/32 (20060101); A61M
25/00 (20060101) |
Field of
Search: |
;600/184 ;606/108
;604/164.01,167.01-167.06,278 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1459688 |
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Sep 2004 |
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EP |
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1518499 |
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Mar 2005 |
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EP |
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05-337076 |
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Dec 1993 |
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JP |
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2000300570 |
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Oct 2000 |
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JP |
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2005-525860 |
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Sep 2005 |
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JP |
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WO-9915068 |
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Apr 1999 |
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WO |
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WO-03053261 |
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Jul 2003 |
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WO |
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03082122 |
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Oct 2003 |
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WO |
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2004/064899 |
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Aug 2004 |
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WO |
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WO-2005089433 |
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Sep 2005 |
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WO |
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Other References
Official Letter from Mexican Institute of Industrial Property,
dated Apr. 2, 2009, 3 pages. cited by applicant .
European Search Report, Application No. 07251893.9, mailed Jun. 12,
2008, 10 pages. cited by applicant .
EP Office Action dated Apr. 29, 2011, App. No. 07251893.9, 7 pages.
cited by applicant .
Japanese Office Action for Application No. 2007-122627, issued Mar.
13, 2012. (5 pages). cited by applicant.
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Primary Examiner: Dowe; Katherine
Parent Case Text
RELATED APPLICATION(S)
The present application is a continuation-in-part of U.S. patent
application Ser. No. 11/382,173, filed on May 8, 2006 and entitled
"Endoscopic Translumenal Surgical Systems," the entirety of which
is incorporated by reference herein.
Claims
What is claimed is:
1. A translumenal trocar device, comprising: a flexible elongate
sleeve having an inner lumen extending between proximal and distal
ends thereof and forming a working channel for receiving and
guiding instruments to a surgical site; a seal disposed within the
inner lumen of the elongate sleeve such that instruments received
in the working channel pass through the seal; an anti-microbial
agent effective to sterilize instruments passed through the lumen
to maintain a sterile surgical site, the anti-microbial agent
comprising at least one of a coating located on the seal and a
material at least partially forming the seal; and an enclosed
reservoir coupled to the elongate sleeve and external to the inner
lumen that is adapted to controllably deliver an anti-microbial
solution to the elongate sleeve for transfer onto an instrument
passed through the lumen.
2. The device of claim 1, further comprising a housing having the
flexible elongate sleeve extending distally therefrom, and a second
seal disposed within the housing that is adapted to form a seal
around instruments passed therethrough.
3. The device of claim 1, wherein the reservoir is configured to
deliver the anti-microbial solution to the seal.
4. The device of claim 1, wherein the anti-microbial agent
comprises an anti-microbial coating disposed on at least a portion
of the elongate sleeve.
5. The device of claim 1, further comprising an obturator removably
disposable through the lumen in the elongate sleeve and having a
distal end adapted to penetrate through tissue.
6. The device of claim 5, wherein the obturator includes an
anti-microbial agent.
7. The device of claim 6, wherein the anti-microbial agent of the
obturator comprises a coating disposed on at least a portion of the
obturator.
8. The device of claim 1, wherein the reservoir is configured to
controllably deliver an amount of the anti-microbial solution to
the elongate sleeve in response to selective opening and closing of
a valve element coupled to the reservoir.
9. The device of claim 8, wherein the valve element comprises a
push-button valve.
10. A method for maintaining a sterile surgical site, comprising:
positioning a flexible tube through a body lumen, the flexible tube
defining a first inner lumen having a sponge disposed therein, and
the flexible tube extending distally from a housing, the housing
defining a second inner lumen having a seal contained therein; and
inserting an instrument through the second inner lumen of the
housing and subsequently through the first inner lumen of the
flexible tube to position a distal end of the instrument adjacent
to a treatment site, the instrument passing through the seal before
passing and directly contacting the sponge, the seal forming a seal
with the instrument passed therethrough, and the seal including an
anti-microbial agent that sterilizes the instrument as it is passed
through the flexible tube.
11. The method of claim 10, wherein positioning the flexible tube
comprises positioning a distal end of the tube adjacent to tissue
to be penetrated while a proximal end of the tube remains outside
of a patient's body.
12. The method of claim 11, further comprising penetrating the
distal end of the instrument through the tissue located adjacent to
the distal end of the tube to position the distal end of the
instrument within a body cavity.
13. The method of claim 12, further comprising removing the
instrument from the body cavity and the flexible tube, the
anti-microbial agent sterilizing the instrument as it is removed,
and introducing a second instrument through the flexible tube, the
anti-microbial agent sterilizing the second instrument as it passed
through the flexible tube.
14. The method of claim 10, wherein the anti-microbial agent
comprises a solution and the method further comprises delivering
the solution to the flexible tube.
15. A translumenal trocar device, comprising: a housing having a
first inner lumen extending therethrough; a flexible elongate
sleeve extending distally from the housing and having a second
inner lumen extending between proximal and distal ends thereof and
being in communication with the first inner lumen, the first and
second inner lumens forming a working channel for receiving and
guiding instruments to a surgical site; a seal disposed within the
second inner lumen of the elongate sleeve such that instruments
received in the working channel pass through the seal; and a sponge
disposed within the second inner lumen of the elongate sleeve such
that instruments received in the working channel pass through and
directly contact the sponge after passing through the seal, the
sponge having an anti-microbial agent contained therein that is
effective to sterilize instruments passed through the lumen to
maintain a sterile surgical site.
16. A method for maintaining a sterile surgical site, comprising:
positioning a flexible tube through a body lumen, the flexible tube
having a seal and a sponge disposed therein, and the flexible tube
extending distally from a housing; and inserting an instrument
through the flexible tube to position a distal end of the
instrument adjacent to a treatment site, the seal having a proximal
end and a distal end, the sponge having a proximal end and a distal
end, and the distal end of the seal being spaced a distance away
from the proximal end of the sponge such that the instrument passes
through the seal before passing through the sponge, the sponge
including an anti-microbial agent that sterilizes the instrument as
it is passed through the flexible tube.
17. The method of claim 16, wherein the anti-microbial agent
comprises a solution that is delivered to the sponge.
Description
FIELD OF THE INVENTION
The present invention relates to methods and devices for endoscopic
translumenal surgery.
BACKGROUND OF THE INVENTION
Endoscopic surgery can be used to access the abdominal cavity via
natural openings (mouth, anus, vagina, urethra) of the body and
through the peritoneal lining of the abdominal cavity. Obviously,
the size and shape of instruments that may be passed through a
bodily lumen in order to perform a medical procedure in the
abdominal cavity are greatly restricted due to the anatomical
properties of the lumen. General surgeons, gastroenterologists, and
other medical specialists, routinely use flexible endoscopes for
intralumenal (within the lumen of the alimentary canal) examination
and treatment of the upper gastrointestinal (GI) tract, via the
mouth, and the lower GI tract, via the anus. In these procedures,
the physician pushes the flexible endoscope into the lumen,
periodically pausing to articulate the distal end of the endoscope
using external control knobs, to redirect the distal tip of the
endoscope. In this way, the physician may navigate the crooked
passageway of the upper GI past the pharynx, through the esophagus
and gastro esophageal junction, and into the stomach. The physician
must take great care not to injure the delicate mucosal lining of
the lumen, which generally may stretch open to a diameter in the
range of about 15-25 mm, but normally has a non-circular cross
sectional configuration when relaxed.
During such translumenal procedures, a puncture must be formed in
the stomach wall or in the gastrointestinal tract to access the
peritoneal cavity. One device often used to form such a puncture is
a needle knife which is inserted through the working channel of the
endoscope, and which utilizes energy to penetrate through the
tissue. A guidewire is then fed through the endoscope and is passed
through the puncture in the stomach wall and into the peritoneal
cavity. The needle knife is removed, leaving the guidewire as a
placeholder. A balloon catheter is then passed over the guidewire
and through the working channel of the endoscope to position the
balloon within the opening in the stomach wall. The balloon can
then be inflated to increase the size of the opening, thereby
enabling the endoscope to push against the rear of the balloon and
to be fed through the opening and into the peritoneal cavity. Once
the endoscope is positioned within the peritoneal cavity, numerous
procedures can be performed through the working channel of the
endoscope.
While current methods and devices used to penetrate tissue are
effective, one drawback is that several exchanges and steps are
required to form the opening in the stomach wall. The small size of
the opening formed can also create high resistance to advancing or
retracting the endoscope, which is significantly larger than the
opening. In the event the endoscope is retracted through the
opening, it can also be difficult to locate the opening and
re-insert the endoscope. Continued advancement and retraction of
the endoscope can also be uncomfortable for the patient.
Additionally, such procedures are prone to contamination in light
of the repeated insertion and withdrawal of instruments along
contaminated environments such as the mouth, esophagus, etc.
Accordingly, there remains a need for improved endoscopic
translumenal methods and devices.
SUMMARY
Methods and devices are provided herein for translumenal access to
a treatment site within a body cavity. In general, the methods and
devices include an anti-microbial agent that is configured to
maintain the sterility of a surgical site. For example, the
anti-microbial agent can be contained within or coated onto various
portions of a medical device, such as a trocar cannula or sleeve
and/or an obturator. Additionally, various portions of the elongate
sleeve and/or obturator can also be formed from a material which
includes an anti-microbial agent. In other embodiments, various
seals and/or sponge elements containing an anti-microbial agent
(e.g., a coating, a solution, a powder, etc.) can be disposed
within a housing and/or disposed within an inner lumen of the
sleeve. In an exemplary embodiment, the anti-microbial agent is
positioned at one or more locations that are effective to sterilize
instruments passing through the device during delivery to and/or
withdrawal from a surgical site.
Various embodiments of a translumenal trocar device are provided
herein. In one such embodiment, a trocar device is provided which
includes a flexible elongate sleeve having an inner lumen extending
between proximal and distal ends thereof and forming a working
channel for receiving and guiding instruments to a surgical site.
The device further includes an anti-microbial agent located within
the inner lumen and effective to sterilize instruments passed
through the lumen to maintain a sterile surgical site. In one
embodiment, the elongate sleeve can include a housing having a seal
formed therein and adapted to form a seal around instruments passed
through the housing and the elongate sleeve. The anti-microbial
agent can be associated with the seal(s). For example, the
anti-microbial agent can be in the form of a coating located on the
seal, the seal can be formed from a material which includes the
anti-microbial agent, and/or the anti-microbial agent can be a
solution disposed on the seal.
In another embodiment, the anti-microbial agent can be associated
with a sponge element disposed within the an inner lumen of the
elongate sleeve, including within a housing portion of the elongate
sleeve. Similar to the embodiment discussed above, the
anti-microbial agent can be in the form of a coating disposed on a
portion of the sponge, and/or an anti-microbial solution disposed
on the sponge element. Where the anti-microbial agent is a
solution, the device can include a reservoir in fluid communication
with the sponge and configured to deliver a desired amount of the
anti-microbial solution to the sponge element.
In other embodiments, the anti-microbial agent can be associated
with various portions of the elongate sleeve. For example, the
anti-microbial agent can be an anti-microbial coating disposed on
at least a portion of the elongate sleeve, such as a distal portion
of the sleeve, an entire length of the sleeve, inner and/or outer
portions of the sleeve, etc. In yet another embodiment, various
portions of the elongate sleeve can be formed from a material which
includes the anti-microbial agent.
In another embodiment, the device can further include an obturator
removably disposable through the lumen in the elongate sleeve, and
having a distal end adapted to penetrate through tissue. Similar to
above, an anti-microbial agent can be associated with various
portions of the obturator. For example, the anti-microbial agent
can be a coating disposed on at least a portion of the obturator
and/or various portions of the obturator can be formed from a
material which includes the anti-microbial agent.
In another embodiment, a translumenal trocar device is provided
which includes a flexible trocar sleeve having an elongate tube
with a housing formed on a proximal end thereof. The trocar sleeve
further includes a lumen extending therethrough, and an obturator
disposed through the lumen in the trocar sleeve and having a distal
tip that extends distally beyond a distal end of the trocar sleeve
such that the distal tip is adapted to guide the obturator and
trocar sleeve through tissue. Additionally, the device includes an
anti-microbial agent associated with at least one of the trocar
sleeve and the obturator.
Various methods for maintaining a sterile surgical site are also
provided herein. In one embodiment, the method can include
positioning a flexible tube through a body lumen, and inserting an
instrument through the flexible tube to position a distal end of
the instrument adjacent to a treatment site. The flexible tube can
include an anti-microbial agent that sterilizes the instrument as
it is passed through the flexible tube. In an exemplary embodiment,
the method can include positioning a distal end of the tube
adjacent to tissue to be penetrated while a proximal end of the
tube remains outside of the patient's body. The method can also
include penetrating the distal end of the instrument through the
tissue located adjacent to the distal end of the tube to position
the distal end of the instrument within a body cavity. The method
can further include removing the instrument from the body cavity
and from the flexible tube such that the anti-microbial agent
associated with the inner lumen of the tube sterilizes the
instrument as it is removed. The method can further include
introducing a second (or any additional number) of instruments
through the flexible tube wherein the anti-microbial agent can
sterilize the second instrument as it passed through the flexible
tube.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more fully understood from the following
detailed description taken in conjunction with the accompanying
drawings, in which:
FIG. 1A is a perspective view of one embodiment of a trocar
assembly having an obturator that houses an endoscope and a trocar
sleeve disposed over the obturator;
FIG. 1B is a perspective view of the obturator of FIG. 1A;
FIG. 1C is a perspective view of the trocar sleeve of FIG. 1A;
FIG. 2 is a cross-sectional view of a housing portion of the trocar
sleeve of FIG. 1C;
FIG. 3 is an exploded view of one embodiment of a seal capable of
being disposed within the housing of FIG. 2;
FIG. 4A is a perspective view of another embodiment of a housing
portion of a trocar sleeve having a reservoir for delivering an
anti-microbial agent to a lumen of the trocar sleeve;
FIG. 4B is a cross sectional view of a portion of the housing of
FIG. 4A;
FIG. 5A is a side, partially cross-sectional view of another
embodiment of a trocar assembly having an end cap mated to a distal
end of an endoscope that is inserted through a trocar sleeve;
FIG. 5B is a side view of the trocar sleeve of FIG. 5A;
FIG. 5C is a side, partially cross-sectional view of the end cap of
FIG. 5A;
FIG. 6A is a perspective view of one exemplary embodiment of a tip
configuration for use with the obturator of FIG. 1A or the end cap
of FIG. 5A;
FIG. 6B is a side view of the tip of FIG. 6A;
FIG. 7A is a side view of another exemplary embodiment of a tip
configuration for use with the obturator of FIG. 1A or the end cap
of FIG. 5A;
FIG. 7B is a perspective view of the tip of FIG. 7A mated to the
distal end of an endoscope;
FIG. 7C is a perspective view of the tip and endoscope of FIG. 7B
inserted through a trocar sleeve;
FIG. 8 is a perspective view of another embodiment of a tip
configuration for use with the obturator of FIG. 1A or the end cap
of FIG. 5A, showing the tip formed on the distal end of an
obturator;
FIG. 9A is an illustration showing the trocar assembly of FIG. 1A
inserted translumenally through an esophagus with the distal end
penetrated through the stomach wall;
FIG. 9B is an illustration showing the trocar assembly of FIG. 9A,
with the obturator and endoscope removed from the trocar sleeve,
and the endoscope about to be re-inserted through the trocar
sleeve;
FIG. 10A is a side view of one embodiment of a protective barrier
for shielding an endoscopic or laparoscopic device during
insertion, showing a distal end of the barrier coupled to an
endoscope; and
FIG. 10B is a side view of the protective barrier and endoscope of
FIG. 10A showing the distal end and an endoscope inserted through
the proximal end of the protective barrier.
DETAILED DESCRIPTION OF THE INVENTION
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those of ordinary skill in the art will
understand that the devices and methods specifically described
herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of the
present invention is defined solely by the claims. The features
illustrated or described in connection with one exemplary
embodiment may be combined with the features of other embodiments.
Such modifications and variations are intended to be included
within the scope of the present invention.
The present invention provides devices for maintaining a sterile
environment around a treatment site during various translumenal
(e.g., transoral and transanal) procedures. In general, the device
can be any device having an elongate sleeve with an inner lumen
configured for providing surgical access to a treatment site. FIGS.
1A-1C illustrate one exemplary embodiment of such a device 10. As
shown, the device 10 includes an obturator 20 slidably disposed
within an elongate sleeve 30. Optionally, the elongate sleeve 30
can include a housing 34 disposed at a proximal end of the sleeve
30. In some embodiments, the obturator 20 can also include an inner
lumen configured to receive and house an endoscope. To maintain
sterility of the treatment site during the procedure, the device 10
can include various anti-microbial agent(s) associated with various
portions of the elongate sleeve 30 and/or various portions of the
obturator 20. As will be discussed in detail below, the agent can
be coated on the elongate sleeve 30 and/or obturator 20, all or
portions of the sleeve 30 and/or obturator 20 can be formed of a
material which includes the anti-microbial agent, and/or the
anti-microbial agent can be a solution that is delivered to the
sleeve 30 and/or obturator 20, or to components thereof such as a
seal and/or sponge element disposed within the elongate sleeve 30
and/or obturator 20. In use, the anti-microbial agent is effective
to sterilize the elongate sleeve 30 and/or instruments (e.g.,
obturator 20, endoscope, etc.) passing through the sleeve 30.
The obturator 20 is shown in more detail in FIG. 1B, and as shown
the obturator 20 includes a hollow, elongate flexible shaft 22
having a proximal end 22a that is coupled to a housing 24 and a
distal end 22b with a tip 26 that is adapted to be inserted through
tissue. The size of the shaft 22 can vary, but it preferably has a
length that allows it to be inserted translumenally, such as
through a patient's esophagus. The obturator 20 can optionally have
a diameter that allows an endoscope to be received therein. The
shaft 22 can be made flexible using various techniques. For
example, the shaft 22 can be formed from a flexible material,
and/or it can include one or more features formed therein to
facilitate flexibility, such as a plurality of cut-outs or slots.
For example, certain portions of the shaft 22, such as the distal
portion, can be more rigid than other portions of the shaft 22,
such as the proximal portion, to correspond to the shape of a body
lumen through which the shaft 22 is being inserted. This can be
achieved by forming the shaft 22 from different materials, varying
the diameter or thickness of the shaft 22, or using various other
techniques know in the art. A person skilled in the art will
appreciate that the shaft 22 can have virtually any configuration
that allows the shaft 22 to flex as it is inserted through a
tortuous body lumen. The shaft 22 can also include other features
to facilitate use, such as one or more spiral wires embedded
therein and configuration to prevent kinking of the shaft 22.
The housing 24 coupled to or formed on the proximal end 22a of the
shaft 22 can have a variety of configurations, but in an exemplary
embodiment the housing 24 is provided to allow the obturator 20 to
removably mate to the elongate sleeve 30. For example, the housing
24 can include one or more mating elements to mate the housing 24
to a housing 34 formed on the elongate sleeve 30, as will be
discussed in more detail below. While virtually any mating
technique can be used, in the illustrated embodiment the housing 24
on the obturator 20 includes first and second tabs (only one tab 25
is shown) that extend distally from a distal surface of the housing
24. The tabs are configured to extend into corresponding bores
formed in the housing 34 on the trocar sleeve 30. The tabs can also
include protrusions formed adjacent to a terminal end thereof to
allow the tabs to be engaged by an engagement mechanism formed
within the bores, thereby fixedly mating the housing 24 on the
obturator 20 to the housing 34 on the elongate sleeve 30. A release
mechanism can be used to release the obturator 20 from the trocar
sleeve 30. As shown in FIG. 1B, the first and second tabs are
coupled to deflectable members (only one tab 25 and one deflectable
member 27 is shown) that extend from opposed lateral sides of the
housing 24. The deflectable members can be depressed to cause the
tabs to move, thereby releasing the tabs from the engaging
mechanism formed in the bores in the trocar sleeve 30. The housing
24 can also optionally include a lumen (not shown) formed
therethrough for receiving an endoscope to allow the endoscope to
be advanced into the obturator 20. A person skilled in the other
will appreciate that various other techniques can be used to mate
the housing 24 of the obturator 20 to the housing 34 of the
elongate sleeve 30, including twist-lock mechanisms, threads,
snap-fit, interference fit, etc. While not shown, where the
obturator 20 is configured to receive an endoscope, an opening
formed in the proximal-most end of the housing 24 can optionally
include a seal disposed therein and effective to engage an outer
surface of the endoscope to seal the endoscope with respect to the
obturator 20. The seal is particularly useful during insufflation
as it can prevent gases from escaping through the assembly. In
particular, the seal can permit the passage of the obturator 20 and
endoscope through the trocar sleeve 30 while limiting or preventing
the passage of fluid or gas therethrough. A person skilled in the
art will appreciate that the housing can include various other
features known in the art, and that the housing can have virtually
any shape and size. The obturator 20 also does not need to include
a housing, but rather can merely be an elongate shaft that is
slidably disposable through a trocar sleeve.
The tip 26 on the distal end 22b of the elongate shaft 22 of the
obturator 20 can also have a variety of configurations. For
example, the tip 26 can be tapered, include blades or wings for
cutting and/or separating tissue. A person skilled in the art will
appreciate that various configurations of the tip are within the
spirit and scope of the present invention. Where the obturator 20
is configured to receive an endoscope, the distal end 22b can be
transparent to facilitate viewing therethrough.
The device 10 also includes an elongate sleeve 30, which is shown
in more detail in FIG. 1C. While the elongate sleeve 30 can have
virtually any configuration, it preferably includes a hollow,
elongate flexible shaft 32 that is configured to provide surgical
access to a treatment site. In those embodiments utilizing an
obturator 20, the outer sleeve 30 can configured to be slidably
disposed over the obturator 20. The size of the flexible shaft 32
of the outer sleeve 30 can vary, but it preferably has a length
that is slightly less then a length of the shaft 22 of the
obturator 20 such that the tip 26 of the obturator 20 extends
distally beyond a distal end 32b of the elongate shaft 32. The
diameter can also vary, but as indicated above, the diameter should
be sufficient to allow the elongate shaft 32 of the trocar sleeve
30 to receive the elongate shaft 22 of the obturator 20 therein.
The elongate shaft 32 of the trocar sleeve 30 can be made flexible
using various techniques known in the art, including those
previously discussed with respect to the elongate shaft 22 of the
obturator 20. In an exemplary embodiment, the trocar sleeve 30 is a
flexible sleeve having a coiled wire wrapped there around or
embedded therein to prevent kinking, and having an interior lining
configured to facilitate smooth passage of the obturator 20
therethrough. The elongate shaft 32 of the trocar sleeve 30 can
also include regions that vary in flexibility, as was also
discussed above with respect to the elongate shaft 22 of the
obturator 20. The trocar sleeve 30 can also include other features
to facilitate use of the trocar sleeve 30 with the obturator 20.
For example, the distal end 32b of the trocar sleeve 30 can have an
outer diameter that tapers distally, as shown, to form a
substantially smooth continuous transition from the trocar sleeve
30 to the tip 26 of the obturator 20. The distal end 32b can also
be angled as shown, or it can have various other
configurations.
The trocar sleeve 30 can also including a housing 34 formed on or
coupled to a proximal end 32a of the elongate shaft 32. The housing
34 can be configured to removably mate to the housing 24 of the
obturator 20, and in particular the housing 34 can include a
proximal end with first and second bores (not shown) formed thereon
and configured to receive the tabs formed on the distal end of the
housing 24 on the obturator 20, as previously explained. As shown
in FIG. 2, the housing 34 can also include an inner lumen formed
therethrough and coaxial with the lumen in the elongate shaft 32 to
allow the elongate shaft 22 of the obturator 20 to be inserted
through the housing 34 and into the elongate shaft 32 of the trocar
sleeve 30. Also, one or more seals 55, 57 can be disposed within
the lumen in the housing 34 to engage an outer surface of the shaft
22 of the obturator 20 or other devices inserted therethrough to
seal the shaft 22 of the obturator 20 or the device with respect to
the trocar sleeve housing 34. Various seals or valve mechanisms are
known in the art, including duck bill or double duck bill valves,
zero-closure valves, septums, gaskets, etc. A person skilled in the
art will appreciate that the housing 34 can include various other
features known in the art, and that the housing 34 can have
virtually any shape and size. Alternatively, the elongate sleeve 30
does not need to include any housing and can merely be in the form
of an elongate shaft.
In an exemplary embodiment, the device 10 further includes an
anti-microbial agent associated with various portions of the
elongate sleeve 30 and/or the obturator 20. As previously
indicated, the anti-microbial agent can be formed on, formed
integrally with, and/or delivered to portions of the sleeve 30
and/or obturator 20 to sterilize instruments passing therethrough.
FIG. 1C shows one exemplary embodiment of an anti-microbial agent
located on a distal portion 51 of the elongate sleeve 30. For
example, the anti-microbial agent can include a coating that is
applied to the distal portion 51 of the elongate sleeve 30,
preferably within the inner lumen of the sleeve 30 such that it
contacts instruments inserted through the sleeve 30. As will be
apparent to those skilled in the art, the anti-microbial coating
can be formed from any anti-microbial material or combination of
such materials capable of providing the desired anti-microbial
effect. For example, in an exemplary embodiment, the coating can
include ionic silver, which is an excellent antimicrobial, with
relatively low toxicity against non-target organisms. In other
embodiments, the distal portion 51 of the elongate sleeve 30 can be
formed from a material that includes the anti-microbial agent. Like
above, such a material and/or anti-microbial agent can include any
such material and/or agent capable of providing the desired effect.
Those skilled in the art will appreciate that the anti-microbial
agent can be associated with virtually any portion of the sleeve
30, including along the entire sleeve 30, along any length of the
sleeve 30, or along multiple portions of the sleeve 30.
Similarly, as shown in FIG. 1B, in those embodiments utilizing an
obturator 20, an anti-microbial agent can also or alternatively be
associated with a portion of the obturator 20, such as a distal
portion 53 thereof. In an exemplary embodiment, the anti-microbial
agent is located along a length of the obturator that is passed
through tissue and into a body cavity (e.g., the abdominal cavity).
In other embodiments, where the obturator 20 includes an inner
lumen, the anti-microbial agent can be located within the inner
lumen of the obturator 20 (such as in those embodiments wherein the
obturator 20 includes an inner lumen configured to receive and/or
house an endoscope). Like above, the anti-microbial agent can be
associated with any portion of the obturator 20, and it can be in
the form of a coating or solution delivered to the obturator, or
portions of the obturator 20 can be formed from a material (or
various materials) which includes the anti-microbial agent.
In another embodiment, the anti-microbial agent can be associated
with a seal 57 disposed within the housing and/or a sponge element
57' disposed within the inner lumen of the elongate sleeve 30
and/or obturator 20. For example, as shown in FIG. 2, an
anti-microbial agent can be associated with at least one of the
seals 55,57 disposed within the housing 34 of the sleeve 30 such
that the anti-microbial agent contacts and thereby sterilizes any
instrument passing through the seal 55, 57. Like above, the
anti-microbial agent can be a coating formed on the seal 55, 57
and/or the seal 55, 57 can be at least partially formed of a
material which includes the anti-microbial agent. For example, the
anti-microbial agent can be a powder disposed on the seal 55, 57.
In another embodiment, the anti-microbial agent can be an
anti-microbial solution that is delivered to the seal 55, 57
thereby allowing the solution to be transferred from the seal 55,
57 to any surgical instrument passing therethrough. The seal 55, 57
can also or alternatively be configured to provide an anti-septic
solution to any instrument passing therethough. For example, the
solution can include a povidone-iodine solution (e.g., polyvinyl
pyrrilidine triiodine solution). Additionally, the solution can
include various surfactants so as to reduce the surface tension of
water and enable any surface active agents to work efficiently. In
other embodiments, the solution can further include various
anti-biotic solutions. Those skilled in the art will appreciate
that any such solution capable of producing any desired therapeutic
effect is within the spirit and scope of the present invention.
FIG. 3 provides an exploded view of an embodiment of a seal 57,
however a person skilled in the art will appreciate that any seal
can be used. As shown, the seal 57 includes a top frame 61, a
bottom frame 73, and a number of over-lapping layers 65, 67, 69, 71
disposed therebetween. In use, the various over-lapping layers 65,
67, 69, 71 can be configured to retain an amount of the
anti-microbial solution and/or powder therebetween. As a surgical
instrument is passed therethrough, the solution can be transferred
from the seal 57 to the instrument thereby sterilizing the
instrument. In another embodiment, the seal can be a thin single
opening lip seal. For example, such a lip seal would have a
thickness of about 0.005 inches to about 0.010 inches. As will be
appreciated by those skilled in the art, the seal can have any
configuration effective to transfer an anti-microbial agent to a
surgical instrument passing therethrough.
In other embodiments, as shown in FIG. 2, the device 10 can include
at least one sponge element 57' disposed within the inner lumen of
the elongate sleeve 30. Similar to the seal 57, an anti-microbial
agent (preferably, a solution) can be associated with the sponge
57' such that the agent can be transferred from the sponge 57' to
any surgical instrument passing therethrough. As will be apparent
to those skilled in the art, the sponge element 57' can be formed
from any material and can have any configuration capable of
retaining an amount of the anti-microbial agent and transferring an
amount of the agent to the instrument passing therethrough.
Moreover, the sponge element 57' can be located within various
portions of the lumen, including within the housing 34 at the
distal end of the shaft 32.
In various embodiments, the seal 57 and/or sponge element 57', or
the lumen itself, can be in fluid communication with a reservoir 59
such that the reservoir 59 is capable of delivering an amount of an
anti-microbial solution from the reservoir 59 to the seal 57,
sponge element 57', or other regions of the device. The reservoir
59 can have various configurations capable of controllably
delivering the anti-microbial agent from the reservoir 59 to the
seal 57, sponge element 57', or lumen. For example, the reservoir
59 can include a valve element capable of controlling flow from the
reservoir to the seal 57, sponge 57', or lumen. In an exemplary
embodiment shown in FIGS. 4A-4B, the reservoir 59 can include a
push-button valve. As shown, the valve includes an exterior button
81 which can be biased by any number of well-known mechanisms in an
extended position. As the button 81 is depressed by a user, a
distal stopper 83 can be pushed inward and away from an opening 83'
thereby allowing the anti-microbial agent to dispense from the
reservoir 59 through the opening 83' to the seal 57, sponge
elements 57', or other regions of the device.
In use, referring back to FIG. 1A, the obturator 20 can be inserted
through and mated to the elongate sleeve 30 (e.g., a trocar sleeve)
to form a flexible trocar assembly 10 that can be used to form a
pathway into a body lumen. In particular, the obturator 20 can be
inserted through the opening in the housing 34 of the trocar sleeve
30, and the housing 24 on the obturator 20 can be mated to the
housing 34 on the trocar sleeve 30. As a result, the tip 26 of the
obturator 20 will extend distally beyond the distal end 32b of the
trocar sleeve 30. At least the distal end of the assembly 10 can be
inserted translumenally, e.g., transorally or transanally, through
a body lumen, and it can be inserted through tissue to gain access
to a body cavity. Exemplary methods for inserting the assembly
translumenally and through tissue will be discussed in more detail
below.
In another embodiment, rather than using an obturator 20 for
inserting the trocar assembly 10 through tissue, an end cap, having
a configuration similar to the tip 26 at the distal end 22b of the
obturator 20, can be removably mated to the distal end of the
endoscope. This is illustrated in FIGS. 5A and 5C, which show an
end cap 40 removably mated to a distal end of an endoscope 50. The
end cap 40 and endoscope 50 can optionally be inserted through a
trocar sleeve 60, as shown in FIGS. 5A and 5B, to form a trocar
assembly 10' that is similar to the trocar assembly 10 previously
described with respect to FIGS. 1A-1C. While not described in
detail, the trocar sleeve 60, shown separately in FIG. 5B, can have
a configuration that is similar to the trocar sleeve 30 previously
described with respect to the embodiment shown in FIGS. 1A-1C. In
use, the end cap 40 can be mated to the distal end of the endoscope
50, and the endoscope 50 and end cap 40 can optionally be inserted
through the trocar sleeve 60 to form a trocar assembly 10'. As
previously explained with respect to the trocar sleeve 30 of FIG.
1C, the trocar sleeve 60 of FIG. 5A can include one or more seals
disposed therein and effective to form a seal with the endoscope 50
inserted therethrough. As further shown in FIG. 5A, when the
endoscope 50 is inserted through the trocar sleeve 60, the end cap
40, or at least the tip portion 40b of the end cap 40, will extend
distally beyond a distal-most end 62b of the trocar sleeve 60 to
allow the tip portion 40b of the end cap 40 to facilitate insertion
of the assembly through tissue. The distal end 62b of the sleeve 60
can have various configurations, as previously explained, to allow
the sleeve 60 and end cap 40 to fit together and have a
substantially smooth continuous outer surface. Once the assembly is
fully mated, at least the distal portion of the assembly can be
inserted translumenally, e.g., transorally or transanally, through
a body lumen, and it can be inserted through tissue to gain access
to a body cavity. Exemplary methods for inserting the assembly
translumenally and through tissue will be discussed in more detail
below.
The end cap 40 can have a variety of configurations, and various
techniques can be used to mate the end cap 40 to the distal end of
an endoscope 50. In one exemplary embodiment, shown in detail in
FIG. 5C, the end cap 40 can have a substantially cylindrical
proximal portion 40a that can be slidably disposed over a
substantially cylindrical distal end of the endoscope 50. The shape
can, however, vary depending on the shape of the endoscope 50. The
proximal portion 40a of the end cap 40 can also be configured to
releasably engage the endoscope 50 to prevent the end cap 40 from
disengaging with the endoscope 50 during use of the device. This
can be achieved using, for example, a resilient material, an
interference fit, a snap-fit, threads, or various other mating
techniques known in the art. As further shown in FIG. 5C, the end
cap 40 can also include a distal tip portion 40b that can be
configured to facilitate insertion of the endoscope 50 through
tissue. The particular configuration of the distal tip 40b can
vary, and various exemplary distal tips will be discussed in more
detail below with respect to FIGS. 6A-8.
The tip 40b at the distal end of the end cap 40 can have a variety
of configurations depending on the intended use. In an exemplary
embodiment, at least a portion and more preferably all of the tip
is transparent or clear to allow an image gathering unit at the
distal end of the endoscope to view and gather images through the
tip. This will allow the endoscope to be used to guide the assembly
through a body lumen and through tissue. The particular
configuration of the transparent portion can vary in order to
further facilitate viewing through the tip. For example, the
materials and shape can be optimized to provide a smooth, clear
viewing surface through which the endoscope can view and gather
images. In one exemplary embodiment, the tip can be shaped so that
a region of the tip is relatively flat. This is illustrated in the
embodiment shown in FIGS. 6A-6B, which illustrate an end cap 70
having a tip 72 with a distal-most region 74 that has a minimal
curvature such that the region 74 is somewhat flattened. In another
exemplary embodiment, as shown in FIGS. 7A-7C, the tip 82 can taper
distally and it can be in the shape of a parabola to prevent
distortion of images gathered therethrough. The tip can also or
alternatively be configured to enlarge an opening in tissue as the
tip is advanced through the tissue. As is shown in FIG. 7A, similar
to the various embodiments discussed above, a portion 53 of the tip
82 can also include an anti-microbial agent. A person skilled in
the art will appreciate that the tip can have a variety of
configurations to facilitate viewing therethrough.
The particular configuration of the tip can also vary depending on
the intended use of the tip. In one embodiment, the tip can have a
configuration that allows the tip to cut and penetrate tissue
through tissue. This can be achieved, for example, using one or
more blades or cutting surfaces formed on the tip. FIGS. 7A and 7B
illustrate one embodiment of an end cap 80 having a tip 82 with
first and second cutting blades 84a, 84b formed on opposed sides
thereof and extending between proximal and distal ends of the tip
82. The cutting blades 84a, 84b protrude above the outer surface of
the tip 82, and have sharp edges to cut through tissue. The cutting
blades 84a, 84b can also be configured to couple to an energy
source to facilitate cutting of tissue. For example, a cautery wire
can be coupled to the blades and it can extend through the
endoscope attached to the end cap 80 to allow a proximal end of the
wire to connect to an energy source. In another embodiment, the
blades can be in the form of paddles that do not cut tissue, but
rather merely extend outward from an outer surface of the tip. The
paddles can have a generally planer, elongate configuration, and in
use they can be configured to separate a cut or slit formed in
tissue. For example, the paddles can be rotated to spread open an
elongate cut made through tissue. The cutting blades can also be
used to spread apart tissue, and/or to facilitate enlargement of a
puncture hole formed through tissue. A person skilled in the art
will appreciate that the cutting blades can be formed integrally
with the tip, such that the tip and blades are formed as a single
piece of material, or they can be separate from and mated to the
tip. As previously mentioned, the tip can also taper distally to
facilitate insertion and penetration through tissue. As further
shown in FIGS. 7A-7C, the tip 82 can also include other features
such as a bore 86 formed in the distal-most end thereof and
configured to receive an endoscopic accessory therethrough, such as
a guide wire, or a cutting element such as a needle knife or
sphinctertome. The assembly can be inserted translumenally along
the endoscopic accessory, or the endoscopic accessory can be
introduced into the device at various stages of a procedure.
In another embodiment, rather than being configured to penetrate
through tissue, the tip can be configured to facilitate insertion
through the tissue and a separate endoscopic accessory can be used
in coordination with the tip. For example, as previously described,
FIGS. 6A-6B illustrate a tip 72 having a region 74 that is
substantially planar. As further shown, the tip 72 can also include
a protruding portion with a bore 76 formed therein for receiving an
endoscopic accessory, such as a guide wire or a cutting tool, such
as a needle knife or sphinctertome. The protruding portion 75 can
be centrally located, but in an exemplary embodiment it is offset
from a central axis of the endoscope so as to allow the protruding
portion 75 to be positioned in axial alignment with a working
channel of the endoscope, and to the allow the planar region 74 to
be positioned in axial alignment with the viewing element in the
endoscope. The protruding portion 75 can also taper distally toward
the bore 76 to facilitate insertion of the tip through tissue.
FIG. 8 illustrates another embodiment of a tip 92, shown formed on
the distal end of an obturator 90, that is preferably configured to
be used in combination with an endoscopic accessory, such as a
guide wire or a cutting tool, such as a needle knife or
sphinctertome. In this embodiment, the tip 92 has a generally
conical configuration and tapers distally toward an opening or bore
96 formed in the distal-most end thereof. The bore 96 is co-axial
with an axis of the endoscope, however since the tip 92 has an
elongated length, any endoscopic accessory inserted through a
working channel of the endoscope can move inward to be inserted
through the bore 96.
A person skilled in the art will appreciate that the tip of the
obturator or the end cap can have a variety of other
configurations, and the tips shown in the figures are merely
exemplary embodiments of tip configurations. By way of non-limiting
example, various other exemplary tip configurations are disclosed
in U.S. Pat. No. 5,591,192 of Privitera et al. entitled "Surgical
Penetration Instrument Including an Imagining Element", and U.S.
Pat. No. 5,569,292 of Scwemberger et al. entitled "Surgical
Penetration Instrument With Transparent Blades and Tip Cover,"
which are hereby incorporated by reference in their entireties. The
tip can also include other features. By way of non-limiting
example, the tip can be configured to be energized to facilitate
insertion and/or penetration of the tip through tissue.
Various embodiments of a method for providing a sterile surgical
site are also provided herein. As discussed in detail above, the
device 10 can include an anti-microbial agent associated with the
elongate sleeve 30 and/or the obturator 20, such as an
anti-microbial seal 57 and/or sponge element 57' can be disposed
within the housing 34 and/or inner lumen of the elongate sleeve 30
of the device, or a coating or material containing an
anti-microbial agent and located within the inner lumen of the
sleeve 30 or located on or within the obturator 20. In light of
these various anti-microbial agents, various translumenal
procedures can be performed while minimizing any contamination of
the treatment site which can occur as bacteria is carried from the
body lumen into the body cavity. As shown in FIGS. 9A-9B, the
method can include positioning a flexible tube through a body lumen
(e.g., the esophagus) 100. Next, the method can include inserting
an instrument through the flexible tube to position a distal end of
the instrument adjacent to a treatment site wherein the flexible
tube includes an anti-microbial agent that sterilizes the
instrument as it is passed through the flexible tube. In an
exemplary embodiment, positioning the flexible tube can include
positioning a distal end of the tube adjacent a tissue to be
penetrated, and a proximal end of the tube remaining outside of a
patient's body. Further, the method can also include penetrating
the distal end of the instrument (e.g., the obturator or any other
instrument) through the tissue located adjacent to the distal end
of the tube to position the distal end of the instrument within the
body cavity (e.g., the abdominal cavity).
In an alternative embodiment, the method can include removing the
instrument from the body cavity and the flexible tube wherein the
inner lumen of the flexible tube can be configured to sterilize the
instrument as the instrument is withdrawn from the treatment site
(e.g., by withdrawing the instrument through the seal and/or sponge
element). The method can further include introducing a second
instrument through the flexible tube wherein the anti-microbial
agent associated with the inner lumen of the tube can also
sterilize the second instrument. Additionally, the method can
include inserting and withdrawing any number of instruments through
the inner lumen wherein the inner lumen is configured to sterilize
the various instruments passing therethrough.
FIGS. 9A and 9B also illustrate an embodiment of a method for
introducing an endoscope translumenally. The method is shown in
conjunction with the device of FIGS. 1A-1C, however a person having
ordinary skill in the art will appreciate that the device of FIGS.
5A-5C can be used, and that the device can have various other
configurations, as previously described herein and as known in the
art. In general, assembled device 10 is inserted translumenally,
e.g., transorally or transanally, to position the distal end of the
assembly at a desired location at which tissue is to be penetrated.
As shown, the assembly is inserted transorally through a patient's
esophagus 100 to position the distal end of the device within the
stomach 102, and to subsequently penetrate through the stomach wall
to position the distal end within the abdominal cavity 104. The
device 10 can optionally be guided through the body lumen using a
steering mechanism on the endoscope 50, using a steering mechanism
that is coupled to the trocar assembly, or using other techniques
known in the art.
Once the distal end of the trocar assembly 10, and optionally an
endoscope 50 disposed therethrough, are positioned at the desired
tissue penetration site, e.g., in the stomach 102, the tip 26 can
be inserted through tissue. As previously explained, various
techniques can be used to penetrate through the tissue. In the
embodiment shown in FIGS. 1A-1C and FIGS. 9A-9B, the tip 26 of the
obturator 20 includes cutting blades formed thereon that can cut
through tissue, allowing the trocar assembly 10 to be directly
penetrated through the tissue. The cutting blades can optionally be
connected to an energy source to cauterize the tissue as the tip 26
is inserted therethrough. Where the tip 26 does not include cutting
blades, such as the tip 72 shown in FIGS. 6A-6B, or in addition to
the cutting blades, a cutting tool, such as a needle knife or
sphinctertome, can be inserted through the working channel of the
obturator, or the endoscope 50 if used, and through the bore 76 in
the tip 72. The needle knife or sphinctertome can then be energized
to penetrate or cut through the tissue. The assembly can be guided
over the needle knife or sphinctertome to guide the tip 72 through
the puncture formed in the tissue by the needle knife, or
alternatively the cutting device can be replaced by a guide wire
and the assembly can be guided over the guide wire through the
puncture. A person skilled in the art will appreciate that various
other techniques can be used to penetrate through the tissue.
Once the distal end of the assembly 10 is inserted through the
tissue, as shown in FIG. 9A, the obturator 20 and endoscope 50 if
used (or, for the embodiment of FIGS. 5A-5C, the end cap 40 and
endoscope 50) can be removed from the trocar sleeve 30. The trocar
sleeve 30 will function as a placeholder for the puncture formed in
the tissue, as the trocar sleeve 30 will remain extending through
the puncture and into the body cavity, e.g., the abdominal cavity,
as shown in FIG. 9B. Where an endoscope is used, the endoscope 50
can then be removed from the obturator 20 (or, for the embodiment
of FIGS. 5A-5C, the end cap 40 can be removed from the endoscope
50), and the endoscope 50 can be reinserted through the trocar
sleeve 30. FIG. 9B illustrates the endoscope 50 about to be
introduced into the trocar sleeve 30. Once the endoscope 50 is
advanced through the trocar sleeve 30 to position the distal end of
the endoscope 50 within the body cavity, e.g., the abdominal cavity
104, various medical procedures can be performed. The trocar sleeve
30 can remain in place or it can be removed leaving the endoscope
50 in place.
While not shown, the assembly can also be used in conjunction with
an expandable member used to expand the size of the puncture hole
to facilitate insertion of the assembly therethrough. For example,
a cutting device can be used to form a puncture in the tissue, and
an expandable member, such as a balloon, disposed on the cutting
device or on a separate device can be advanced and positioned
within the puncture. The expandable member can then be expanded to
increase the size of the puncture. The endoscope can then be
advanced, pushing the expanded expandable member and the endoscope
through the puncture. Where this technique is used, it may not be
necessary to use an obturator or end cap with the endoscope.
Rather, the trocar sleeve can be positioned over the endoscope and
passed through the puncture with the endoscope. The endoscope and
expandable member can then be removed, leaving the trocar sleeve in
place for receiving other devices therethrough.
In another embodiment, a protective barrier is provided to
facilitate insertion of an endoscopic device, such as an endoscope,
overtube, trocar assembly, or any other endoscopic device, through
a body lumen. FIGS. 10A-10B illustrate one exemplary embodiment of
a protective barrier 200 and method for using the same. The
particular configuration of the barrier 200 can vary, but in an
exemplary embodiment the barrier 200 has a generally elongate
hollow configuration with proximal and distal ends 200a, 200b. One
of the ends, e.g., the distal end 200b, can be adapted to mate or
attach to a distal end of an endoscopic device, such as endoscope
50, and the other end, e.g., the proximal end 200a, can be
configured to remain external to the patient or to be disposed and
retained within an opening to a body lumen, such as the patient's
oral cavity. The particular configuration of each end can vary. For
example, the distal end 200b can be formed from a resilient
material to allow the distal end 200b to be disposed over and
engage an endoscope 50 or other device. The proximal end 200a can
be shaped to fit within an opening of a body cavity, such as an
oral cavity, or it can merely be a terminal end of the tube. In an
exemplary embodiment, the proximal end 200a is flared outward to
facilitate introduction of the endoscope 50 or other device and
distal end 200b of the barrier 200 therethrough. In other
embodiments, where the barrier 200 is formed from a resilient
material, the ends 200a, 200b can merely be rolled over or folded
onto themselves to form a soft terminal end surface.
At least a portion of the barrier 200 can also be formed from a
flexible or resilient material to facilitate insertion of at least
the flexible or resilient portion through tissue. In the embodiment
shown in FIGS. 10A-10B, the entire barrier 200 is flexible to allow
the mid-portion of the barrier 200 to be inserted translumenally,
as will be discussed in more detail below. In other embodiments,
the barrier can include a flexible or resilient portion and a
portion that is more rigid. For example, the barrier can be formed
using a standard overtube and a flexible sheath that is coupled to
the overtube. In use, as will be discussed below, the overtube can
form an inner sleeve of the device, and the flexible sheath can
form an outer sleeve. The use of an overtube can provide support to
the esophagus, which may be important in certain applications, such
as an obese patient, prior conditions and operations, etc.
In use, as shown in FIGS. 10A-10B, a mid-portion 200c of the
barrier 200 is inserted translumenally preferably through the
entire length of the body lumen, such as an esophagus, while the
proximal and distal ends 200a, 200b remain outside of or just
within the opening to the body cavity. Various inserter tools known
in the art can be used to insert the mid-portion translumenally.
For example, at least one support rod 300 can be positioned between
the proximal end distal ends 200a, 200b of the barrier 200 and it
can be advanced into the mid-portion 200c of the barrier 200 and
through a body lumen to insert the mid-portion 200c through the
body lumen. As a result, the barrier 200 will include an inner
sheath and an outer sheath that extend through the lumen. Where the
barrier includes an overtube or other more rigid portion, the
flexible portion can form the outer sleeve, and the overtube can
form the inner sleeve. Alternatively, the flexible portion can have
a length that allows the flexible portion to form both the inner
and outer sleeves, and the overtube can remain outside the
body.
The distal end 200b of the barrier 200 can be coupled to an
endoscopic device, such as endoscope 50, and once the mid-portion
200c is inserted through the body lumen, the endoscope 50, with the
distal end 200b of the barrier 200 attached thereto, can be
inserted into the proximal end 200a of the barrier 200 and through
the body lumen. Again, where the barrier includes an overtube, the
overtube can couple to the endoscope or other device and the
overtube and endoscope can be inserted together through the
flexible portion. As the endoscope 50 is being inserted through the
barrier 200, the barrier 200 will prevent contact between the
endoscope 50 and the body lumen, thereby shielding the endoscope 50
and preventing any bacteria within the body lumen from being
brought into a body cavity, such as the stomach. In an exemplary
embodiment, the barrier 200 preferably has a length that allows the
barrier 200 to extend through the entire body lumen, such as the
esophagus, and into, for example, the stomach so there is no
contact between the endoscope and the esophagus. Once the endoscope
50 is positioned in the stomach or other body lumen, various other
procedures, such as those previously described, can be performed.
For example, an endoscopic accessory can be inserted through the
endoscopic device to facilitate insertion of the endoscopic device
through tissue. A person skilled in the art will appreciate that
the barrier can be used in a variety of endoscopic and laparoscopic
procedures, and it can have a variety of configurations to
facilitate mating to and use with an endoscopic or laparoscopic
device.
In another exemplary embodiment, the various devices disclosed
herein, or portions thereof, can be designed to be disposed of
after a single use, or they can be designed to be used multiple
times. For example, after at least one use, the device can be
disassembled, followed by cleaning or replacement of particular
pieces, and subsequent reassembly. By way of example, the end cap
disclosed herein can be provided as a kit containing multiple end
caps (the sizes can be the same or they can vary). After at least
one use of the device, the end cap can be removed, the endoscope
can be cleaned, and a new end cap can be placed on the endoscope to
prepare for subsequent use. The various other devices disclosed
herein can also be disassembled after at least one use, and any
number of the particular pieces can be selectively replaced or
removed in any combination. Replacement of pieces can also include
replacement of portions of particular elements. Upon cleaning
and/or replacement of particular parts, the device can be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning can
utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
One skilled in the art will appreciate further features and
advantages of the invention based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
* * * * *